- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00459121
Vandetanib, Carboplatin, and Paclitaxel in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed by Surgery
Assessment of Feasibility and Safety of the Addition of ZD6474 (Zactima) to Carboplatin and Paclitaxel Administered Neo-Adjuvantly in Stage IB, II and T3, N1 Non-Small Cell Lung Cancer (NSCLC)
RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vandetanib together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving vandetanib together with carboplatin and paclitaxel works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Determine the feasibility of neoadjuvant vandetanib in combination with carboplatin and paclitaxel in patients with resectable stage IB, II, or IIIA non-small cell lung cancer.
Secondary
- Assess the 30-day postoperative mortality rate in these patients.
- Assess the toxicity of this regimen in these patients.
- Determine the percentage of patients who complete all planned courses of therapy.
- Assess the clinical response rate in patients treated with this regimen.
- Assess the pathologic complete response rate in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral vandetanib once daily on days 1-21. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 3 courses.
Patients undergo surgery at least 3 weeks after the last course of chemotherapy.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following staging criteria:
- Stage IB or II disease
- T3, N0-1 disease (stage IIIA)
- Deemed a surgical candidate
- No prior lung cancer (NSCLC or small cell lung cancer)
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the investigator, would preclude study compliance
- No peripheral neuropathy ≥ grade 2
- No hemoptysis within the past 12 weeks
- No spontaneous bleeding within the past 12 weeks
- No clinically significant cardiac event (e.g., NYHA class II-IV heart disease, myocardial infarction) within the past 3 months
No history of asymptomatic sustained ventricular tachycardia or arrhythmia that is symptomatic or requires treatment, including any of the following:
- Multifocal premature ventricular contractions
- Bigeminy
- Trigeminy
- Ventricular tachycardia
Uncontrolled atrial fibrillation
- Atrial fibrillation controlled with medication allowed
- No history of QTc prolongation as a result from other medication that required discontinuation of that medication
- No congenital long QT syndrome or first-degree family relative with an unexplained death before the age of 40
- No left bundle branch block
No QTc with Bazett's correction that is unmeasurable or QTc ≥ 480 milliseconds on screening ECG
Patients with QTc ≥ 480 milliseconds on screening ECG may have ECG repeated twice
- Average QTc from the 3 screening ECG's must be < 480 milliseconds
- No uncontrolled hypertension (systolic BP > 160 mm Hg or diastolic BP > 100 mm Hg)
- No active diarrhea or active gastrointestinal disease that may affect the absorption of study drugs or ability to tolerate study drugs
- No other malignancy within the past 3 years except in situ cervical carcinoma or adequately treated basal cell or squamous cell carcinoma of the skin
PRIOR CONCURRENT THERAPY:
- More than 4 weeks since major surgery and recovered
- No prior carboplatin, paclitaxel, or vandetanib
- More than 30 days since prior investigational agents
More than 2 weeks since prior and no concurrent drugs that induce CYP3A4 including, but not limited to, any of the following:
- Rifampin
- Phenytoin
- Carbamazepine
- Barbiturates
- Hypericum perforatum (St. John's wort)
- No medication that may cause QTc prolongation or induce torsades de pointes for 2 weeks prior to beginning study treatment, during, and for 2 weeks after completion of study treatment
- No concurrent combination antiretroviral treatment for HIV-positive patients
- No other concurrent investigational agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Zactima, Paclitaxel, Carboplatin
Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle. Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment. |
Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1
Other Names:
Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1.
Other Names:
Zactima- 100 mg orally daily, starting on day 1 of cycle 1.
Other Names:
Neoadjuvant surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complete Resection (R0) Rate
Time Frame: Following three cycles of pre-operative zactima and carboplatin/paclitaxel
|
Following three cycles of pre-operative zactima and carboplatin/paclitaxel
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-Operative Mortality Rate
Time Frame: at 30 days
|
at 30 days
|
|
Assess Toxicity of This Regimen and the Percentage of Patients Completing All Planned Cycles of Therapy
Time Frame: Weekly for the first cycle; Thereafter within 72 hours of each dose of carboplatin/paclitaxel
|
Serum chemistry includes Albumin, alkaline phosphatase, total bilirubin, bicarbonate, BUN, calcium, chloride, creatinine, glucose, potassium, total protein, SGOT [AST], SGPT [ALT], sodium, laboratory tests should be done on a weekly basis for the first cycle.
After the first cycle laboratory tests should be done within 72 hours of each dose of carboplatin/paclitaxel.
|
Weekly for the first cycle; Thereafter within 72 hours of each dose of carboplatin/paclitaxel
|
Assess the Clinical Response Rate of the Proposed Pre-operative Regimen
Time Frame: End of three cycles of treatment
|
Patients will undergo tumor evaluation when all of the three cycles have been completed unless the treating physician has concerns regarding tumor progression.
If the patient has undergone tumor evaluation prior to the last cycle the patient will require repeat tumor assessment within 4 weeks of completion of the last cycle of therapy
|
End of three cycles of treatment
|
Assess the Complete Pathologic Complete Response (CR) Rate With This Regimen.
Time Frame: 30 days post surgery
|
Evaluation of the number of patients who have no evidence of tumor in the resected tumor.
|
30 days post surgery
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- CDR0000539273
- P30CA022453 (U.S. NIH Grant/Contract)
- WSU-2006-122 (OTHER: Barbara Ann Karmanos Cancer Institute)
- WSU-011807MP2F (OTHER: Wayne State University - Human Investigation Committee)
- WSU-0612004427 (OTHER: Wayne State University - Human Investigation Committee)
- ZENECA-IRUSZACT0029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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